Institutional Review Board (IRB): Consent Letters

 Email us at irb@ncu.edu

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You are required to write a consent letter for your IRB application if all of the following are true:

1. You plan to conduct human subjects research
2. You will be recruiting participants who are age 18+
3. AND You will be doing research outside of an everyday educational setting

If you plan to conduct research with students in an everyday educational setting, you may need to use an Information Letter instead.

If you will be recruiting minors under age 17 for research in a non-educational setting, you will write a Child Assent Letter & Parental Consent Letter.

You will write a consent letter so that potential participants have all the information about your study in one place and can make an informed decision as to whether they want to participate in your study. A consent letter is just one part of the informed consent process. Informed consent is an ongoing process that begins during recruitment and continues throughout the study.

How do I collect consent?

If you are engaging with participants in real-time (interviews, focus groups, observations, etc.), you may send potential participants a copy of the consent letter before you meet with them. You then must do the following:

1. Set aside time to read through the consent letter with each participant. As you read through, remind participants that they do not have to participate if they do not want to, they can skip any question they do not want to answer, they can skip any activity they do not want to participate in, and they can stop participating at any time.
2. Give participants an opportunity to ask questions about your study.
3. Ask participants for verbal consent (e.g., "Do you still want to participate in this study?"). For Exempt and Expedited studies, the NCU IRB does not require you to collect participant signatures or any written documentation of consent (if you are using a site IRB, they may require participant signatures). For more information, watch the webinar below:

If you are distributing an Online Survey or Questionnaire, you will do the following:

• Place your consent letter on the first page of your survey
• Have a question that asks participants if they agree or disagree to be in your study
• Do not allow participants who disagree to view or answer the survey questions

When do I collect consent?

After you have received IRB approval. You should not consent participants or collect data until you have IRB approval.

You are required to use the NCU IRB consent letter template below, unless you are working with an IRB/ HRPP that require you to use their template.

• IRB Consent Letter Template (required)

You will also be required to provide a Readability Report for your consent letter.

The following webinar shows you how to write your consent letter:

Do I need to reword the template to avoid plagiarism?

No! Using a required template is not plagiarism. The consent letter template has language that is required by federal regulations. You should not change or revise any of the template language.

Get feedback on your consent letter

The NCU IRB recommends that you receive feedback on your consent letter before you submit your IRB application:

• Attend a Group Writing Session
• Submit for IRB Document Review

You will upload your consent letter in the "Consent" section of your IRB application.

The documents you upload to your IRB application should be ready to send to the participants. Double-check the following:

• Don't change or reword any of the required template language
• Remove all blue highlighting, template instructions, and optional sections that aren't applicable to your study
• Remove any Track Changes or comments from your chair or the IRB
• Do not include any labeling or formatting from your dissertation (Appendix, etc.)

• IRB Consent Letter Template (required; last updated 3.4.21)
• Consent Letter Examples